MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 39565-30, serial/lot #: (b)(4), ubd: (b)(6) 2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain and postlaminectomy pain.It was reported that the patient had a revision/ the patient mentioned that they had a revision of the lead last wednesday and just prior to the surgery the manufacturer's representative (rep) wanted to read the patient's oms, but determined that the ins was "super uncharged or something." the patients lead needed to be revised, "because it stopped working", stating that when the ins was on the patient was getting "jolts." the patient turned the ins off.The patient stated that they were not told that you have to continue to charge the ins even though the ins is off, so the patient cannot charge the ins or use therapy.The lead revision occurred on (b)(6).No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported that their battery was still good, but that it was discharging.No further complications were reported or anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7739621
• MDR Text Key: 115704170
• Report Number: 3004209178-2018-17150
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 08/08/2018
• Supplement Dates FDA Received: 08/02/2018; 10/04/2018
• Date Device Manufactured: 12/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR